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Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-01012-1
Product Name/Description	Cook Beacon Tip Angiography Catheters Beacon Tip Torcon NB Advantage Catheters Catalogue Prefix: HNBR4.0, HNBR4.1 and only HNBR5.0 w/RUC Suffix Beacon Tip Royal Flush Plus High-Flow Catheters Catalogue Prefix: HNR4.0 Slip-Cath Beacon Tip Catheters Catalogue Prefix: SCBR4.0, SCBR4.1, and only SCBR5.0 w/RUC Suffix Shuttle Select Slip-Cath, 4 FR Shuttle System Compatible Catalogue Prefix: SCBR4.5 Multiple Lot Numbers affected ARTG Numbers: 137861, 154909, 154911, 137865
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	14/10/2015
Responsible Entity	William A Cook Australia Pty Ltd
Reason/Issue	Cook Medical is initiating a recall of all lots in distribution following reports of catheter tip splits and/or separation. Potential adverse events that may occur as a result of catheter tip splitting and or separation may include the loss of device function, medical intervention to retrieve the separated segment, or complications resulting from the separated tip occluding blood flow to end organs.
Recall Action	Recall
Recall Action Instructions	Cook Medical is advising users to inspect and quarantine any affected lots for return to Cook Medical.
Contact Information	1800 777 222 - Cook Medical